Tocilizumab-aazg for Brain Aneurysm

(THRIVE Trial)

Overseen By Brian Hoh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Florida

Must not be taking: IL-6 inhibitors, Anti-CD20, others

Disqualifiers: Vasospasm, Hemodynamic instability, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the drug tocilizumab-aazg (TYENNE) is safe and can help prevent strokes after a burst brain aneurysm, which is a weakened area in a blood vessel that has leaked blood into the brain. The study administers an infusion of the medication shortly after the aneurysm occurs. Individuals who have experienced a burst brain aneurysm in the last 24 hours and have specific drainage devices in place might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been treated with certain medications like IL-6 inhibitors or other specific therapies within a certain timeframe before the trial, you may not be eligible to participate.

Is there any evidence suggesting that tocilizumab-aazg is likely to be safe for humans?

Research has shown that tocilizumab-aazg has been tested for safety in people with burst brain aneurysms. So far, the treatment appears safe and well-tolerated. Previous studies have identified no new safety issues. Tocilizumab-aazg resembles a drug already approved for other uses, which provides some confidence about its safety. However, as this is an early-stage trial, much remains to be learned about its long-term effects. Participants should consider these points when deciding whether to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain aneurysms, which often involve surgical interventions or endovascular procedures, tocilizumab-aazg offers a novel approach by using an intravenous infusion. This treatment is particularly exciting because it targets inflammation, which is not the primary focus of current standard therapies. By potentially reducing inflammation following a subarachnoid hemorrhage, tocilizumab-aazg could offer an innovative way to mitigate damage and improve recovery outcomes. Researchers are hopeful that this new method could complement existing treatments and offer additional benefits to patients experiencing brain aneurysms.

What evidence suggests that tocilizumab-aazg might be an effective treatment for brain aneurysm?

Research has shown that tocilizumab-aazg, which participants in this trial will receive, might help prevent strokes after a brain aneurysm bursts. Studies indicate that this medication can reduce inflammation and lessen the severity of vasospasms, sudden narrowings of blood vessels. This is important because vasospasms can cause additional brain damage. Although more research is needed, these early findings suggest that tocilizumab-aazg could help protect the brain from further injury after an aneurysm. ^{2 3 4 6 7}

Who Is on the Research Team?

Brian Hoh, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for patients who've had a burst brain aneurysm, which can lead to subarachnoid hemorrhage and increase the risk of stroke and cognitive issues. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I have or will have a drain placed in my head or spine.

I am an adult with a mild to moderate brain hemorrhage from a ruptured aneurysm, diagnosed within the last day.

Signed informed consent from subject or legally authorized representative

Exclusion Criteria

Illicit drug or alcohol abuse within 12 months prior to screening

I have difficulty with blood draws or IV insertions due to poor vein access.

I do not have active or untreated TB or lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive tocilizumab-aazg 6mg/kg IV infusion drip on Day 0 following subarachnoid hemorrhage

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and laboratory measures

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Tocilizumab-aazg

Trial Overview

The study tests tocilizumab-aazg (TYENNE), focusing on its safety in those with a recent burst brain aneurysm and its potential to prevent further strokes or cerebral ischemia following such an event.

How Is the Trial Designed?

Group I: tocilizumab-aazg (TYENNE) Experimental Treatment 1 Intervention

Participants will receive tocilizumab-aazg 6mg/kg IV infusion drip on Day 0 following subarachnoid hemorrhage and enrollment in the trial.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1.

withpower.com

withpower.com/trial/phase-1-subarachnoid-hemorrhage-6-2025-d6aa8

Tocilizumab-aazg for Brain Aneurysm (THRIVE Trial)

This trial is for patients who've had a burst brain aneurysm, which can lead to subarachnoid hemorrhage and increase the risk of stroke and cognitive issues.

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06863480/tocilizumab-aazg-for-hemorrhage-reduction-of-ischemic-vascular-events?activelyRecruiting=false&page=433&id=42&slug=cerebral-ischemia

Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic ...

In this study, tocilizumab-aazg (TYENNE) will be administered to see whether tocilizumab-aazg is safe in patients with a burst brain ...

3.

ctv.veeva.com

ctv.veeva.com/study/tocilizumab-aazg-for-hemorrhage-reduction-of-ischemic-vascular-events

Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic ...

The trial is designed to demonstrate safety and to detect a signal that tocilizumab-aazg prevents delayed cerebral ischemia in these patients.

4.

app.trialscreen.org

app.trialscreen.org/trials/phase-1-tocilizumab-aazg-hemorrhage-reduction-ischemic-vascular-events-trial-nct06863480

Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic ...

Benefits: Participants will receive a investigational treatment that may help prevent strokes and other brain injuries after a ruptured aneurysm. They will also ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39768906/

The Comparative Effects of Anakinra and Tocilizumab on ...

Anakinra and tocilizumab treatments significantly reduced inflammatory markers and vasospasm severity compared to the SAH group (p < 0.05).

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06863480

Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic ...

... tocilizumab-aazg is safe in patients with a burst brain aneurysm and if it may prevent strokes in patients with a burst brain aneurysm. Detailed Description.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10683736/

Safety and pharmacodynamic efficacy of eculizumab in ...

One dose of eculizumab did not result in a ⩾ 55% decrease in C5a concentration in CSF on day 3 after aSAH. The study did not reveal new safety concerns.